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TAVNEOS® (avacopan) is not a steroid. It is a targeted therapy that was designed to block a receptor involved inANCA-associated vasculitis.
TAVNEOS was studied in a clinical trial that aimed to test whether participants could achieve and sustain remissionThe period in which a disease and its symptoms decreases or subsides. .To test this, trial participants were given either TAVNEOS or a steroid (also known as prednisone, which was reduced according to a set schedule). Both groups received rituximab or cyclophosphamide and azathioprine.
TAVNEOS was studied in a clinical trial involving 330 adults living with ANCA-associated vasculitis over 52 weeks
Adults who used TAVNEOS in combination with standard therapy had fewer relapses
1 out of 10 people (10.1%) treated with TAVNEOS experienced a relapseA return of symptoms and disease that had previously improved. , compared with 2 out of 10 people (21%) taking prednisone.
This was a secondary endpoint in the study. While secondary endpoints were determined before the trial began, they should be considered a lower level of evidence and interpreted with caution. There is potential for secondary endpoint results that don’t accurately represent the population, and these endpoints were not statistically pre-ranked and may be subject to statistical bias. Talk to your doctor if you have any questions about whether TAVNEOS may be right for you.
Everyone in the study was allowed to use steroids as needed, regardless of what treatment they used. However, those treated with TAVNEOS in combination with standard therapy had a lower medianThe median represents the middle value in a list of the total doses for each group of patients (TAVNEOS in combination with standard therapy versus prednisone and standard therapy). To find this number, a list is ordered from lowest total dose to highest total dose, and the middle number is selected. If there isn’t one middle number, an average of the 2 middle numbers can be used. total dose of steroids than people taking prednisone and standard therapy (400 mg versus 2939 mg).
Kidney function improved for adults who used TAVNEOS in combination with standard therapy
Kidneys are a pair of very important organs. The main function of your kidneys is to filter your blood by removing waste and extra water to make urine. To see how well your kidneys are working, your doctor may check the estimated glomerular filtration rate, or eGFR. Your eGFR will tell your doctor if you have kidney disease, and if so, what stage. The percentage of kidney function goes down as kidney disease gets worse.
This was a secondary endpoint in the study. While secondary endpoints were determined before the trial began, they should be considered a lower level of evidence and interpreted with caution. There is potential for secondary endpoint results that don’t accurately represent the population, and these endpoints were not statistically pre-ranked and may be subject to statistical bias. Talk to your doctor if you have any questions about whether TAVNEOS may be right for you.
Talk to
your doctor
about adding TAVNEOS today
if you’re still
experiencing signs and
symptoms of
ANCA-associated
vasculitis.
The most common side effects are nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation. However, these are not all of the possible side effects that may occur with TAVNEOS.
Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients of this medicine. See the Medication Guide for a complete list of the ingredients in TAVNEOS.
These could be signs of an allergic reaction. Do not take any more TAVNEOS until you have consulted with your healthcare provider.
TAVNEOS can cause serious side effects, including:
Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS.
including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAVNEOS and certain other medicines may affect each other and cause side effects. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist.
The most common side effects of TAVNEOS include:
TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody(ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).
It is not known if TAVNEOS is safe and effective in children under the age of 18.
These are not all the possible side effects of TAVNEOS. Call your doctor for medical advice about side effects. Please see the Full Prescribing Information and Medication Guide for further details.
TAVNEOS is available as a 10 mg capsule.
You are encouraged to report negative side effects to 1-833-828-6367 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-332-1088.
IMPORTANT SAFETY INFORMATION
TAVNEOS can cause serious side effects, including:
TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active